Events

Rappel de Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifunction patient monitoring)All PDMs produced from April 2007 through June 2010

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01255-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01255-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Fluid can pass through the seals in the top cover and come into contact with energised contacts in the circuit board. this can result in heat buildup, smoke, and discoloration. this heat buildup could potentially result in thermal injury to a patient or a caregiver.
  • Action
    GE Healthcare is advising users to inspect the top cover for signs of heat buildup or discolouration. Remove from use if any evidence of damage is observed. GE is advising users to refrain from spraying fluid onto device. A new cover will be installed on all affected devices as a permanent fix when available. This action has been closed-out on 11/02/2016.

Device

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifuncti...
  • Modèle / numéro de série
    Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifunction patient monitoring)All PDMs produced from April 2007 through June 2010Serial Numbers: SA30713XXXXXX to SA31026XXXXXXARTG Number: 118982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd